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A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX

NCT00319592 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-08-20

Study results available
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Summary

The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous virus strain and several wild types strains after completion of vaccination course.

Conditions

  • Japanese Encephalitis

Interventions

BIOLOGICAL

ChimeriVax™-JE vaccine

0.5 mL, subcutaneously

BIOLOGICAL

JE-VAX® vaccine

1.0 mL, subcutaneously

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Nancy L Abdou, MD · PRA Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2006-09-30
Completion
2006-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00319592 on ClinicalTrials.gov